Orthodontic brackets and systems are widely used to assist in the straightening or realignment of teeth. The orthodontic brackets are often abrasive against the interior surfaces of one's mouth that has orthodontic braces. Currently there are only a few systems used to prevent abrasion to the interior surfaces of the mouth/wearer caused by braces and other orthodontic device(s) worn in the mouth and all have significant drawbacks. Traditionally, users have mostly used orthodontic relief wax, such as the GUM® brand Orthodontic Wax, to provide protection against abrasion by orthodontic devices; however, this wax is generally provided in small cases and a user repeatedly uses his/her fingers to access the wax, which is potentially unsanitary.
Other solutions to provide protection of the surfaces of a mouth against abrasive surfaces of orthodontic devices such as the use of uncured (uncrosslinked) silicone high consistency rubber alone or uncured (uncrosslinked) silicone high consistency rubber base coated on and present only on the surface with a surface adhesive layer that is an aqueous-based (and subsequently dehydrated) layer of one of a few hygroscopic materials including polyvinylpyrrolidones, starches and gums. Yet other solutions make use of two-part silicone rubber systems that require premixing the parts followed by application to the offending bracket or brackets, followed by a rapid cure during which crosslinking to rubber occurs. Silicone rubbers generally are well known throughout a variety of industries and applications. They are produced in a variety of manners that lead to a cured (crosslinked) R2SiO— polymeric network (R=an organic function such as but not limited to methyl, phenyl, vinyl). Hallmarks of silicone rubber are its hydrophobicity and low surface energy, making adhesion to silicone rubber surfaces a difficult task. It is for this reason that paper is often coated with silicone rubber to serve as a surface from which self-adhering articles such as postage stamps and name tags can be easily removed and applied elsewhere even though they are coated on one surface with a pressure sensitive adhesive. One particular form of crosslinked silicone rubber, known as High Consistency Rubber (HCR), is generated from an uncured (uncrosslinked) silicone HCR base material that consists of one or more silicones, including but not limited to, polydimethylsiloxanes, vinyl-functional polydimethylsiloxanes, silanol-functional polydimethylsiloxanes, Si—H functional polydimethylsiloxanes. The uncured (uncrosslinked) silicone high consistency base material is converted to silicone HCR by inducing curing (crosslinking) by including an appropriate crosslinking catalyst. What differentiates silicone rubber from silicone HCR is that silicone HCR contains an appreciable amount of silica filler mixed into the uncured base material before crosslinking. To achieve a level of silicone polymer and silica filler interaction that provides a stable product while maintaining the reinforcing nature of the filler in the crosslinked elastomer, a treatment, or pacification, of the silanol species on the reinforcing silica filler is necessary. This is typically carried out either through the addition of silanol-end blocked polydimethylsiloxane oligomers or via a capping reaction using reactive silanes or silazanes. Nearly all applications involving silicone HCR uncured (uncrosslinked) base involve its combination with an appropriate cure catalyst (typically peroxides or compounds of platinum) and heating, resulting in crosslinking reactions and a conversion of the silicone HCR uncured base to silicone HCR. There are, however, a few commercial uses of the uncured (uncrosslinked) silicone HCR base such as ear plugs. Another commercial use of uncured (uncrosslinked) silicone HCR base is marketed as OrthoSil™ silicone wax for Orthodontic Patients. Meant to be a superior substitute for traditional hydrocarbon-based orthodontic relief wax to protect the soft tissues of the mouth from irritation and abrasion caused by orthodontic appliances, it has the advantage over wax of being more pliable and comfortable. However, like the traditional hydrocarbon based relief-wax formulations, it has the disadvantage of being unable to adhere to wet teeth and braces due to the hydrophobicity and low surface energy associated with silicones. As a result, the instructions for use of OrthoSil™ recommend well drying of the teeth and brackets to which the OrthoSil™ is to be applied, an often difficult if not virtually impossible task (orthodontic brackets tend to serve as wells for pools of saliva). The instructions state: “Your brackets must be completely dry for silicone wax to adhere properly.” Obviously, this is difficult to achieve in the typical conditions of the mouth and given the many surfaces of a typical bracket where saliva gathers.
Another product that uses uncured (uncrosslinked) silicone HCR base is described in US Patent Application Publication No. US 2015/0209120 A1, the disclosure of which is hereby incorporated by reference in its entirety. The uncured (uncrosslinked) silicone HCR base material has a coating of adhesive on its surface to help secure the material onto wet teeth and brackets. The aqueous solution of adhesive is applied to the surface of the uncured (uncrosslinked) silicone HCR base material and then optionally dried. However, this still suffers drawbacks, including the requirement for expensive packaging with appropriate moisture (ambient humidity) barrier to keep the adhesive dry until use, which is not necessary in connection with the material of the present disclosure described herein, and the potential for the user applying the wrong side (the side without adhesive) to the teeth and brackets, in which case it will fail to adhere to wet teeth and braces.